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OpenTrials
Active, Not Recruiting

NCT Number: NCT06828718

The Neoadjuvant Treatment Modalities in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (NEO-EC)

The prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma were compared with different neoadjuvant therapy modes in multi-cancer centers in China

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shijiazhuang, Hebei, China

About this study

Neoadjuvant chemoradiotherapy or neoadjuvant chemotherapy combined with surgery are the main treatment methods for patients with locally advanced esophageal squamous cell carcinoma, but some patients still have local recurrence or distant metastasis after surgery. In the era of immunotherapy, immune checkpoint inhibitor monotherapy or combined chemotherapy has become the first-line and second-line standard treatment for recurrent or metastatic esophageal cancer and has been recommended by NCCN guidelines. However, relevant studies on immunotherapy's participation in neoadjuvant therapy have shown good results, but it is still in its initial stage, and its efficacy needs further research and discussion.Thus, we compared the prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma who received different neoadjuvant therapy before surgery, including neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy, neoadjuvant chemotherapy combined with immunotherapy, and neoadjuvant chemoradiotherapy combined with immunotherapy in several cancer centers in China.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years, male or female;
  • KPS score (KPS) ≥70;
  • Esophageal squamous cell carcinoma confirmed by histopathology;
  • Clinical stage cT1b-4aN+M0,T3-4aN0M0;
  • Surgical resection was performed after 2~4 cycles of neoadjuvant therapy.
  • Expected survival > 6 months.

Exclusion criteria

  • Have a history of other malignancies (except for cancer in situ that has been cured and other malignancies that have been cured for more than 5 years);
  • There are contraindications of immunotherapy or chemoradiotherapy;
  • Inability to tolerate or refuse surgery;
  • Distant metastasis has occurred;

Treatment and study plan

Primary outcomes

  1. Comparison of pathological complete response rate (pCR) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy

    Time frame: 2015.1.1-2023.12.31

    Pathological complete response (pCR) is defined as the absence of residual tumor cells after evaluation of removed tumor tissue and regional lymph nodes.

  2. Comparison of major pathological response (MPR) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy

    Time frame: 2015.1.1-2023.12.31

    Major pathological response (MPR) is defined as a tumor that has significantly shrunk or decreased in the pathological evaluation, but still has a small number of residual tumor cells.

Secondary outcomes

  1. Comparison of the overall survival (OS) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy

    Time frame: 2015.1.1-2025.12.31

    OS is defined as the time from the start of enrollment to death from any cause

  2. Comparison of the disease-free survival (DFS) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy

    Time frame: 2015.1.1-2025.12.31

    DFS difined as the time between the start of the enrollment and the recurrence of disease, or death from any cause.

Other outcomes

  1. Comparison of incidence of treatment-related adverse evants after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy

    Time frame: 2015.1.1-2025.12.31

    Adverse events are observed during the course of the study and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0).

Sponsors and collaborators

Lead sponsor

Hebei Medical University Fourth Hospital

Other

Collaborators

  • Fujian Cancer Hospital
  • Jiangsu Cancer Institute & Hospital
  • Shandong Cancer Hospital and Institute
  • Shanxi Province Cancer Hospital
  • Sichuan Cancer Hospital and Research Institute
  • Tianjin Medical University Cancer Institute and Hospital

Registry information

Official study title

Comparison of the Prognosis and Safety of Different Neoadjuvant Treatment Modalities in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma: A National Multicenter Real-World Study(NEO-EC)

Acronym: NEO-EC

Important dates

Study start
2015
Primary completion
2025
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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